Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

Summary

The FDA issued a Class II for Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), by Medline Industries, LP. Reason: During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that .

Details

Product Description

Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,

Lot/Code Info: Medline Kit Number/SKU CDS780056K: UDI/DI each 10888277941373, UDI/DI case 40888277941374, Lot Number: 21DBU610; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21KBG946; Medline Kit Number/SKU CDS780056L: UDI/DI each 10193489897593, UDI/DI case 40193489897594, Lot Number: 21IBV394; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23IBO480; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23FBL915; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23EBP966; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23DBB223; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23CBO553; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 23ABG956; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22KBD840; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22IBK666; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22HBZ276; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22GBK671; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22FBI951; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22EBE862; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22OBA987; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 22BBC815; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21KBC808; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21HBM967; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21FBD640; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBN004; Medline Kit Number/SKU CDS780109O: UDI/DI each 10193489332865, UDI/DI case 40193489332866, Lot Number: 21DBB965; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBU070; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25BBS617; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABT989; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABR939; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 25ABE858; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBU114; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBB359; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24KBA010; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBP286; Medline Kit Number/SKU CDS780109Q: UDI/DI each 10198459094859, UDI/DI case 40198459094850, Lot Number: 24IBI821; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26BBJ914; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 26ABU117; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25KBB123; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25JBJ200; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBX170; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25GBD249; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBV077; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25FBB825; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25BBS499; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 25ABF429; Medline Kit Number/SKU CDS780119W: UDI/DI each 10198459186240, UDI/DI case 40198459186241, Lot Number: 24LBK961; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABU440; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 23ABM574; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22KBM775; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22IBN540; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22HBH464; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22EBM543; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22DBL468; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22BBQ627; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 22ABH903; Medline Kit Number/SKU CDS780208F: UDI/DI each 10193489494211, UDI/DI case 40193489494212, Lot Number: 21FBD429; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23HMF568; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23GMD696; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMG749; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23EMF336; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMG955; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23DMB891; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 23BMF118; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22EMF683; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22CMB893; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AME418; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 22AMB644; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21HMG159; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21GMD475; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21EME444; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 21CKA528; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24CMH800; Medline Kit Number/SKU CDS780230K: UDI/DI each 10888277749788, UDI/DI case 40888277749789, Lot Number: 24AME651; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25EMC695; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25DMH430; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25CMC383; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 25BMA577; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24LMF931; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24IMI022; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24HMD414; Medline Kit Number/SKU CDS780230L: UDI/DI each 10198459021572, UDI/DI case 40198459021573, Lot Number: 24GMF641; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25LMB182; Medline Kit Number/SKU CDS780230M: UDI/DI each 10198459371530, UDI/DI case 40198459371531, Lot Number: 25JME944; Medline Kit Number/SKU CDS840193AA: UDI/DI each 10198459624650, UDI/DI case 40198459624651, Lot Number: 26BBI688; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22IMA515; Medline Kit Number/SKU CDS981327Q: UDI/DI each 10195327080365, UDI/DI case 40195327080366, Lot Number: 22GMH480; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25DMA275; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25CMC073; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25BMH093; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 25AMJ526; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24KMC461; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24JMG627; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24IMA421; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMJ886; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMI364; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24FMC468; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24EMJ857; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME653; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 24DME236; Medline Kit Number/SKU CDS981327R: UDI/DI each 10195327539238, UDI/DI case 40195327539239, Lot Number: 23LMH592; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26BMD798; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMJ740; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 26AMK056; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25KME621; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25HMI011; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25GMD593; Medline Kit Number/SKU CDS981327S: UDI/DI each 10198459344428, UDI/DI case 40198459344429, Lot Number: 25EMJ777; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21KMB552; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21JMA057; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21IMG287; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21HMH155; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21GMD446; Medline Kit Number/SKU CDS982598J: UDI/DI each 10193489814835, UDI/DI case 40193489814836, Lot Number: 21CKA360; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 23BBE227; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22LBR320; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22JBD908; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22HBC474; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22FBR329; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22EBD183; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22DBL896; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 22BBQ901; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21KBZ661; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21KBD925; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21HBB507; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21FBC705; Medline Kit Number/SKU CDS982704N: UDI/DI each 10193489418118, UDI/DI case 40193489418119, Lot Number: 21DBF391; Medline Kit Number/SKU CDS983067O: UDI/DI each 10193489923919, UDI/DI case 40193489923910, Lot Number: 21GBW329; Medline Kit Number/SKU CDS983067O: UDI/DI each 10193489923919, UDI/DI case 40193489923910, Lot Number: 21GBW330; Medline Kit Number/SKU CDS983067P: UDI/DI each 10193489992410, UDI/DI case 40193489992411, Lot Number: 21JBI914; Medline Kit Number/SKU CDS983067Q: UDI/DI each 10195327014414, UDI/DI case 40195327014415, Lot Number: 21VBA261; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22KBR625; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22JBA128; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22IBG254; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22HBE402; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22HBB675; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22GBT165; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22FBL412; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBI098; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBF807; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22OBA439; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22BBN430; Medline Kit Number/SKU CDS983067R: UDI/DI each 10195327066284, UDI/DI case 40195327066285, Lot Number: 22ABR754; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23EBN868; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23DBO557; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23DBA498; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23CBO871; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23ABD958; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 23ABE748; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22LBC196; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22EBV250; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22EBU143; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 22CBM750; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25FBF374; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25FBD169; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25ABQ324; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 25ABF107; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24KBG200; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24JBA335; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24HBG928; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24GBY600; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24FBS184; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24EBV541; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24EBA092; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24DBJ888; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24CBT420; Medline Kit Number/SKU CDS983186J: UDI/DI each 10195327105624, UDI/DI case 40195327105625, Lot Number: 24BBN502; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 26BBU064; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 26BBE547; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25JBJ027; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25IBE728; Medline Kit Number/SKU CDS983186K: UDI/DI each 10198459413407, UDI/DI case 40198459413408, Lot Number: 25HBC629; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21IBD823; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21FBA066; Medline Kit Number/SKU CDS983383G: UDI/DI each 10193489820379, UDI/DI case 40193489820370, Lot Number: 21DBT982; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22JBH486; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22HBJ838; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22GBW341; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22EBQ443; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22EBR513; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22CBJ547; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 22BBQ628; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21JBQ856; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21JBD152; Medline Kit Number/SKU CDS983383I: UDI/DI each 10193489987515, UDI/DI case 40193489987516, Lot Number: 21IBS277; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23IBU124; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23HBJ253; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23FBL780; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23DBE062; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23BBG735; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 22LBG966; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 22KBK505; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 24BBK578; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 24BBE238; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23LBP200; Medline Kit Number/SKU CDS983383J: UDI/DI each 10195327247997, UDI/DI case 40195327247998, Lot Number: 23KBW057; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 25ABF837; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24LBF687; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24JBX543; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24JBN204; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24IBI682; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24HBE586; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24GBH753; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24FBF076; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24DBS374; Medline Kit Number/SKU CDS983383K: UDI/DI each 10195327638245, UDI/DI case 40195327638246, Lot Number: 24CBG287; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 26BBA010; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25LBC092; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25JBO557; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25IBA300; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25GBM558; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25FBQ369; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25FBH080; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25DBR706; Medline Kit Number/SKU CDS983383L: UDI/DI each 10198459224577, UDI/DI case 40198459224578, Lot Number: 25BBS434; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23EBE364; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23CBU024; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 23CBN738; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22KBS879; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22KBU352; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22IBS408; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22EBF941; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 22DBC999; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 21KBW920; Medline Kit Number/SKU CDS983882D: UDI/DI each 10193489435948, UDI/DI case 40193489435949, Lot Number: 21DBO237; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 26BBI689; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 26ABJ517; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25IBS521; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25HBR957; Medline Kit Number/SKU CDS983882I: UDI/DI each 10198459429774, UDI/DI case 40198459429775, Lot Number: 25HBF943; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23FBL260; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23EBU951; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23EBK997; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23CBI556; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23ABL469; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 23ABN789; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22KBS655; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22JBJ163; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22FBX184; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22FBH437; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22EBF942; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22DBB159; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 22CLA523; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21JBX843; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21JBS156; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21IBU462; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21HBQ028; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21FBE881; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21FBE882; Medline Kit Number/SKU CDS983885D: UDI/DI each 10193489435092, UDI/DI case 40193489435093, Lot Number: 21CBT329; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25CBJ495; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25BBI017; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 25ABD227; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24KBQ712; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24JBK509; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24JBH672; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24HBO308; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24GBH754; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24DBB586; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24CBJ688; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 24ABB735; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 23KBU576; Medline Kit Number/SKU CDS983885F: UDI/DI each 10195327418250, UDI/DI case 40195327418251, Lot Number: 23KBU834; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25JBX514; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25IBU968; Medline Kit Number/SKU CDS983885I: UDI/DI each 10198459429729, UDI/DI case 40198459429720, Lot Number: 25HBF944; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 22ABZ200; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21KBA430; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21GBE942; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21DBE159; Medline Kit Number/SKU CDS983981J: UDI/DI each 10193489312065, UDI/DI case 40193489312066, Lot Number: 21BBF817; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 23ABG042; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22HBM662; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22HBM664; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22EBI118; Medline Kit Number/SKU CDS983981K: UDI/DI each 10195327086923, UDI/DI case 40195327086924, Lot Number: 22EBG587; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23KBN899; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23KBN714; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23IBU172; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23IBT871; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23GBT893; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23GBK552; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 23FBN470; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24IBR079; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24IBD748; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24HBO845; Medline Kit Number/SKU CDS983981L: UDI/DI each 10195327337476, UDI/DI case 40195327337477, Lot Number: 24HBE588; Medline Kit Number/SKU CDS983981L: UDI/DI each 101953

Quantity Affected: 538201 kits

Reason for Recall

During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market product may be out-of-specification for endotoxin.

Type: Voluntary: Firm initiated

Recall Initiated: 2026-03-19

Company